NCT02956889

To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma

A Single Arm, Phase II, Multicenter Study To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Patients With High Risk Or Locally Advanced Basal Cell Carcinoma Not Amenable To Radical Surgery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable). The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks). The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.

Detailed description

This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable). The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks). The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point. The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months. The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS) and overall survival (OS); to assess the response in terms of overall response rate (ORR) (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)); to assess duration of response (DoR); to assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) ;to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)

Conditions

• Carcinoma, Basal Cell

Interventions

Type	Name	Description
DRUG	Vismodegib	Patients will receive a continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg .
RADIATION	Radiotherapy	Radiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-02-01
• Completion: 2020-01-01
• First posted: 2016-11-07
• Last updated: 2020-01-29

Locations

1 site across 1 country: Italy